Because severe, even fatal, blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with the use of Felbatol , it should be used only in people with severe epilepsy and only after careful consideration. Aplastic anemia may occur even after the drug has been stopped. Felbatol is not recommended for use in patients who have liver problems. Stop using Felbatol and immediately notify your doctor if you have symptoms of infection such as fever, chills, or persistent sore throat, or if you have unusual bleeding or bruising, weakness, fatigue, dark urine, yellowing of the eyes or skin, or persistent stomach/abdominal pain. Your doctor will perform liver function tests before starting Felbatol and every 1 to 2 weeks while you are using Felbatol .
Treating certain types of seizures.
Felbatol is an anticonvulsant. It works by controlling nerve impulses in the brain, which prevents or reduces some types of seizures.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Felbatol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Felbatol . Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Felbatol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Felbatol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Felbatol .
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; headache; itching; loss of appetite; nausea; tiredness; upset stomach; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; dark urine; fever, chills, or sore throat; mental or mood changes (eg, depression, mood swings); mouth sores; nervousness or anxiety; suicidal thoughts or actions; unusual bruising or bleeding; vision changes; weakness; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fast heartbeat; upset stomach.Proper storage of Felbatol :
Store Felbatol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Felbatol out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Felbatol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.